Epilepsy, Post-Traumatic
Conditions
Brief summary
Post-traumatic seizures can appear frequently after a severe traumatic brain injury. Two types of seizures are usually identified: early seizures during the week following the trauma and late epilepsy afterward. Several antiepileptic drugs are usually used to prevent early seizures but no treatment has demonstrated any preventive effect against late epilepsy. Levetiracetam is an antiepileptic drug usually used for the treatment of epileptic patients and has pharmacologic properties that could also be interesting for the prevention of post-traumatic epilepsy.
Interventions
DRUGLevetiracetam
1500 mg/day orally until the first episode of late epilepsy for a maximum duration of 3 months
DRUGPlacebo
1500 mg/day orally until the first episode of late epilepsy for a maximum duration of 3 months
Sponsors
UCB Pharma
Rennes University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Age \>= 18 years old 2. Patient with severe brain injury defined as follow: * Initial Glasgow Coma score (assessed on the scene of the accident) \<= 8 related to the brain injury * Stage 2 to 4 on the TDM US TCDB classification 3. Initial brain CT scan performed within 48 hours after hospital admission 4. Either a male or a nonpregnant, non-lactating female who is using adequate contraceptive method (a urine laboratory pregnancy test must be negative at baseline) 5. Written informed consent from the patient's next-of-kin. If no relative is present as the time of inclusion, the patients will be included according to the emergency procedure
Exclusion criteria
1. Isolated extradural hematoma 2. Medical decision to limit patient's care (terminal stage of a cancer, hematological malignancies, HIV, etc.) 3. Current participation in an other protocol or within one month before study entry 4. Previous treatment with Levetiracetam 5. Patient's follow-up judged to be difficult by the investigator 6. Known allergy to either Levetiracetam or products derived from pyrrolidone or one of its excipients 7. Epileptic patient treated or not (except patients treated with benzodiazepines who can be included in this protocol)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Time to early epileptic seizures (<= 8 days) and late epilepsy (from day 9 to 1 year) in patients with severe traumatic brain injury | one year |
Secondary
| Measure | Time frame |
|---|---|
| Rate of early seizures and of late epilepsy; treatment effects according to the patient's severity, the TDM US Traumatic Coma Data Bank, and the number of regions traumatized; safety of Levetiracetam | One year |
| Global prognosis (Glasgow Outcome Scale) | 3 months, 6 months and 1 year |
Countries
France
Outcome results
None listed